National snakebite project on capacity building of health system on prevention and management of snakebite envenoming including its complications in selected districts of Maharashtra and Odisha in India: A study protocol

Background Snakebite envenoming (SBE) is an acute, life-threatening emergency in tropical and subtropical countries. It is an occupational hazard and a major socioeconomic determinant. Limited awareness, superstitions, lack of trained health providers, poor utilization of anti-venom results in high mortality and morbidity. India is the snakebite capital of the world. Yet, information on awareness, knowledge, and perceptions about snakebite is limited. Data on capacity building of health systems and its potential impact is lacking. Recommended by the National Task Force on snakebite research in India, this protocol describes the National Snakebite Project aiming for capacity building of health systems on prevention and management of snakebite envenomation in Maharashtra and Odisha states. Methods A cross-sectional, multi-centric study will be carried out in Shahapur, Aheri blocks of Maharashtra, and Khordha, Kasipur blocks of Odisha. The study has five phases: Phase I involves the collection of retrospective baseline data of snakebites, facility surveys, and community focus group discussions (FGDs). Phase II involves developing and implementing educational intervention programs for the community. Phase III will assess the knowledge and practices of the healthcare providers on snakebite management followed by their training in Phase IV. Phase V will evaluate the impact of the interventions on the community and healthcare system through FGDs and comparison of prospective and baseline data. Discussion The National Snakebite Project will use a multi-sectoral approach to reduce the burden of SBE. It intends to contribute to community empowerment and capacity building of the public healthcare system on the prevention and management of SBE. The results could be useful for upscaling to other Indian states, South Asia and other tropical countries. The findings of the study will provide critical regional inputs for the revision of the National Snakebite Treatment protocol. Trial registration Registered under the Clinical Trials Registry India no. CTRI/2021/11/038137.


RESEARCH PROTOCOL
Title of the Study: ICMR National Snakebite Project (INSP) on capacity building of health system on prevention and management of snakebite envenomation including its complications

Study duration: 2 years
Objectives of the study:

I.
To increase the awareness and empower the community on prevention, first aid and early transport of snakebite patients to nearest health facility for reducing the mortality and morbidity due to snakebite envenomation in selected districts of Maharashtra and Orissa II.
To evaluate the component of training of the Medical Officers and other healthcare providers on management of snakebite and also understand the ASVs distribution and utilization (availability, factors restricting availability, quantity) in public health facilities in selected districts of Maharashtra and Orissa III.
To empower the health system for management of snakebite envenomation and optimal utilization of Anti snake venoms (ASVs) through implementation of Standard Treatment Guidelines (STG) of Government of India IV.
To study the impact of capacity building of health system on reducing the mortality and morbidity due to snakebite envenomation in selected districts of Maharashtra and Orissa

Introduction
Snakebite envenoming is a neglected tropical disease (NTD) resulting from injection of venom (mixture of highly specialized toxins) by venomous snake into humans usually under accidental circumstances. Snakebite envenoming most commonly affects poor, agricultural and migrant workers, tribes, hunters, often earning member of their families, and thus it is not only a public health problem, but also a major socioeconomic challenge especially in India. Globally, around 81,000 to 138,000 deaths were estimated resulting from 1.8 million to 2.7 million cases of snakebite envenoming and leading to around 400 000 people with permanent physical or psychological disabilities including blindness, amputation, and post-traumatic stress disorder 1 .
However, the snakebite burden is likely to be an underestimate as snakebite is not a notifiable disease and many bites and deaths go unrecorded. The death and disability burden of snakebite is equivalent to that of prostate or cervical cancer, and is greater than any other neglected tropical disease. 2 Despite this, it has been a low priority to the, research funding agencies, health authorities and pharmaceutical companies worldwide.
According to National mortality survey (2001)(2002)(2003), India constitutes almost half of the global snakebite burden with estimated mortality ranging from 45,000 to 50,000 every year 3 . This study also reported higher annual age-standardized mortality rates per 100,000 population due to snakebite in 13 states : Andhra Prades (6.2), Madhya Pradesh (5.9), Odisha (5.6), Jhrakhand (4.9), Bihar (4.9), Tamilnadu (4.7), Uttar Pradesh ( Echis carinatus (Saw scaled viper). 5,6 There are regional differences in the snakebite species reported in different parts of India. 7 Currently, treatment quality is highly variable from good quality in some areas to very poor in other areas. The high fatality due to Krait bite is attributed to the non-availability of anti-snake venom (ASV), delayed and inappropriate administration of ASV, lack of standard protocol for management and inexperienced doctors and ventilator or bag and valve 8 . In India, there has always been a crisis of antivenom supply 9 .
The Snakebite envenoming was classified by WHO as a high-priority neglected tropical disease In 2017, and subsequently in May, 2018, Seventy-first World Health Assembly (WHA) adopted a resolution that provides a strong mandate to WHO for global actions on reducing the burden of snake bite envenoming 10  • ASV skin testing was observed as a common clinical practice in tribal block of Dahanu, Maharashtra, India leading to wastage of precious ASVs. 14 (Moreover, we observed that majority of the medical officers posted at PHC do not treat the snakebite patients mainly due to fear of anaphylaxis and lack of confidence in ASV administration. • Training manuals were prepared in local language (Marathi) for ASHA, ANM, MPW on prevention, diagnosis and management of snakebite based on the standard treatment guidelines (STG, 2017) developed by Government of India.
• IEC materials were developed in local language (Marathi) for empowerment of the community and primary health care system to empower them on snakebite prevention, diagnosis and management.
• Capacity building of outreach health workers (ASHA,ANM and MPW) was carried out Sample Size: All ASHA/ANM/MPW, Medical Officers from the study area will be requested to participate in the study. A total of 24 Master Trainers (6 per study block) will be trained by National Experts Based on our earlier experience of snakebite study conducted in Dahanu block, each block will have approximately 40 Medical Officers; so for the proposed study total MOs undergoing training will be 160. Similarly, training will also be provided to outreach healthcare workers including ASHA, ANM, MPW. Approximately, 150 outreach healthcare workers per block will be trained so a total of 600 healthcare workers will be trained in 4 blocks. Actual numbers will vary and the same MOs or Health care workers may not be available throughout the study duration as there are frequent transfers of MOs and Healthcare staff due to various reasons.

Preparatory Phase (6 months) Technical Advisory Committee (TAC) Members:
-Snakebite management experts (National and State) -Program managers in MoHFW, Government of India and Public Health Department Maharashtra, and the Odisha States -Herpetologists and Forest department representatives from the study area -Researchers with experience in health system research, snakebite -ICMR/DHR representatives Activities and responsibilities of TAC: -National consultation meetings for the development of IEC materials, training manuals, and research tools Research Tools: -Research tools will be revised based on the consultation meetings taking into consideration region-specific factors -Culturally appropriate IEC materials will be developed in regional language Baseline/retrospective data collection : Two-year retrospective data will be collected from all the public health facilities in study areas. The data collection form will capture information on socio-demographic characteristics, the total number of snakebite cases (OPD/IPD), deaths due to snakebites, signs, and symptoms, first aid, and usage of ASV, treatment practices, etc wherever available from the hospital records. The data on snakebite deaths will also be collected from the municipal corporation records, gram panchayat, crematorium or any other institutions wherever available in the study areas to ensure that all deaths due to snakebite are captured in addition to data from hospital records.
Focus group discussions (FGDs): FGDs will be conducted in each study area. FGDs will be conducted separately for males and females. The selection of male and female participants for FGD will be as per the convenience of the participants. Inclusion criteria: 1) Participants belonging to the community 2) Willing and able to actively participate 3) Above 18 years Exclusion Criteria: 1) Participants not belonging to the community 2) Health workers directly and indirectly involved in snakebite management In each block, we will conduct total 6 FGDs ( 3 males, 3 females). A total of 24 FGDs will be conducted but the number of FGDs will vary according to saturation of responses. Each FGD will be restricted to 8 to 16 participants.The selection of male and female participants for FGD will be as per the convenience of the participants. Study participants will be given a copy of participant information sheet and informed consent form shared and explained in vernacular language (Regional Language) to ensure voluntary participation. The research team will facilitate the discussion about perception, knowledge, awareness on snakes and snakebites, prevention methods, first aid practices, healthcare-seeking behavior of the community for snakebites. Audiotapes of the participant discussion will be recorded and notes will be taken. Themes and subthemes will be identified based on the transcripts and coding analysis will be carried out. Two or three trial FGDs will also be conducted to understand the community awareness before the study. This data will not be accounted for the analysis.
-Interview of outreach Health Care Providers Assessment (ASHA/ANM/MPW) to assess the knowledge gaps using a pre-tested and validated questionnaire.
-Interview of Medical Officers (PHC/CHC/DH) to assess the knowledge gaps using a pre-tested and validated questionnaire.
-Infrastructure Assessment (Facility check survey) The developed questionnaire will be validated through, face validity, content, and construct validity. Any unclear questionnaire below 50% (percentage of correct responses overall) will be rewritten. The readability of the questionnaire will be assessed using the Simple Measure of Gobbledygook (SMOG) score.

Interventions:
IEC materials in local language for the community, snake rescuers (Sarpa Mitra/snake friends) school teachers, panchayat members, and traditional healers. The IEC materials will include the following information: -Pictures of the venomous snakes commonly found in the study area -Knowledge about venomous and non-venomous snakes -Symptoms of snakebite envenomation in simple non-medical terms in regional language -Prevention of snakebites and first aid treatment -Nearest health facility for snakebite treatment (distance in kms, contact numbers of health facilities), ambulance services 102,108 information The IEC materials will be displayed at Schools, Gram Panchayat in villages, Anganawadi, Tribal Residential Schools, Block panchayat Office, Sub Centers, PHCs, CHCs.

Community meetings and Public talks:
-ICMR snakebite project staff, and primary health care workers (ASHA, ANM and MPW) will be trained to educate community through community meetings for creating awareness on prevention, first aid and early transport of snakebite patients to nearest health facility ➢ Periodic training of all Medical Officers working in public health system in study area will be conducted every 6 months.
➢ All medical officers will be provided copies of Training modules prepared as per the Standardized Treatment Guidelines (STG, 2017) -Quick reference guide -Snakebite treatment flyer Detailed Training will cover following aspects: -When to suspect/recognize snakebite.
-Four presenting clinical syndromes of snakebites.
-First aid measures at health care facility.
-Signs and symptoms of snakebite envenomation.
-Patient assessment on arrivalcritical, non-critical and critical after stabilization -Examination of pregnant women.
-Level specific management of snake bite and Referral criteria.
-Snake bite management at PHC, CHC, DH and higher facilities

Duration of Master Trainer training: 2 days
-Lecture and practical demonstration with exercises in small groups.

Snakebite training of MOs will be conducted every 6 months for 2 years
• Master Trainers will conduct the training of Medical Officers in their respective study area -Periodic Training (every 6 months for 2 years) of health care providers will be conducted on snakebite prevention, diagnosis and management -Training will also focus on first aid skills, immobilization techniques, cardiopulmonary resuscitation (CPR) etc.
-Medical Officers trained by Master trainers will conduct the training program for ASHA, ANM, MPW and other healthcare providers at their respective health facilities.
-Training manuals for ASHA, ANM, MPW, and other healthcare providers developed by ICMR-NIRRH will be translated into regional languages -Pre and post training evaluation to assess knowledge retention and assess impact of training Quick reference charts as per STG (2017) on first aid and management of snakebite in English and regional languages will be displayed in OPD and indoor wards of PHC, CHC, in study area.

Monitoring and supervision of implementation of Standard Treatment Guidelines (STG, 2017)
for snakebite Management.
• Periodic supervision at Sub centre, PHC, CHC to ensure snake management as per Standard • For Maharshtra state: Notification of snakebite cases to SDH Shahapur, Thane District and SDH

Aheri in Gadchiroli
• Strict monitoring will be carried out to ensure that every snakebite patient is managed as per STG, 2017.
• The details of the snakebite treatment will be entered in a prospective data collection form signed by the head of the health facility. Project Staff will ensure the weekly collection of prospective data forms and data entry operator will enter the data regularly in a centralized database.
• Site Co-PI, Co-Is and Scientist C -Medical (project staff) will be responsible for monitoring the record of total number snakebite cases in each health facility.
• Details of Cases managed at PHC, CHC referred to higher centers (DH and/ Medical College) will be recorded • Total number of deaths due to snakebite will be recorded before and after capacity building -Treatment of severe snakebite envenomation and management of complications will be evaluated

Capacity building of peripheral healthcare workers
Objective IV: To study the impact of capacity building of health system on reducing the mortality and morbidity due to snakebite envenomation in selected districts of Maharashtra and Orissa -The impact of capacity building will be measured by periodic data analysis -FGDs will be conducted in the selected study sites to assess the impact of intervention -The results of this study will be useful for finalization of National Snakebite Management Protocol relevant to public health system taking into consideration regional differences in India.
-The study will empower the community and health system for prevention and improved management of snakebites in selected regions in Maharashtra and Odisha.
-The results of the study will be crucial for establishing centers of excellence for snakebite management in Maharashtra and Odisha.

b) Long term:
-The results of the study will help in reducing the mortality and morbidity due to snakebites in selected regions in India and also useful for phase II implementation in other states having high burden of snakebites.
-The evidence generated from the study may be useful to the Government of India for developing National Strategies to reduce burden of on snakebites.
-Model clinical snakebite management centers can be established all over country based on the outcome of the study Bibliography